ZERONA— 510(k) K133718
Substantially EquivalentErchonia Corporation
FDA 510(k) clearance K133718 for ZERONA, Substantially Equivalent on 2014-05-12. Applicant: Erchonia Corporation. Device class: 2.
Clearance details
- Applicant
- Erchonia Corporation
- Product code
- Code OLI
- Device class
- Class 2
- Regulation
- 21 CFR 878.5400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Littleton, CO, US
Recent devices under product code OLI
view allMore clearances from Erchonia Corporation
view allData sourced from openFDA. This site is unofficial and independent of the FDA.